GMP compliance

GMP requirements are a set of standards that are recognized around the globe. These standards aim to ensure drug quality and safety – for both raw and finished material.

Below are some of the aspects of our business that achieve GMP compliance:

• Third-party ISO 9001:2015 certified QMS implemented that incorporates GMP and quality risk management.
• Supported quality agreement structures via ADLI Logistics or client agreements. Quality agreements detail many topics such as batch/lot numbering, deviations, recalls, audits, and inspections.
• Good documentation practices (GDP) in effect as a part of our ISO 9001:2015 certified QMS.
• Clean, hygienic, and pest-free facilities that undergo daily facility audits to ensure compliance with GMP standards.
• In-house semi-automated continuous feed pallet washer to ensure clean, sanitary pallets are only used for your products.
• SOPs implemented and reviewed for effectiveness and adherence to GMP standards. Some of these include product storage and handling to mitigate the risk of the product’s quality.
• Deviation process that documents and reviews any action that strays from our GMP compliant and ISO 9001:2015 certified processes. Root cause investigation and assessment of any corrective and preventative actions (CAPA) are taken.
• System in place to manage recalls – batch/lot activity traceability.
• Trained staff to carry out procedures.
• Facility maintenance to ensure facilities are in a great state of repair.

Recalls

We are your one point-of-contact when it comes to helping you manage any finished or raw pharmaceutical recalls. With your dedicated customer service representative, you will be put into contact with the correct people in the business to ensure the quickest response time to coordinate the recall throughout your supply chain.

If you have a detailed procedure to handle a recall, share it with us and we will work with you to ensure a recall is handled the way you have defined it.

Maintain and regulate humidity for moisture-sensitive pharmaceuticals

ADLI Logistics also offers temperature-and humidity-controlled environments to ensure that your temperature and/or humidity sensitive raw and finished pharmaceuticals are stored in the ideal requirements for health, safety, and product integrity.

Cold/refrigerated storage

Our cooler provides refrigerated storage within the range of 2-8 C (36-46 F) to ensure that your regulated and/or non-regulated finished and raw pharmaceutical drugs are stored at the optimal temperature to keep product integrity and product safety at an ideal level.

Warehouse Management System Capabilities

With our WMS, ADLI Logistics can provide you with the following perks:

• Automated receiving and shipping notifications – know exactly when an order has been fully received into inventory or has left one of our facilities.
• Daily, weekly, and monthly reporting offerings – Inventory, receiving, and shipping summary reports.
• Client portal to place orders and view inventory and historical data.
• Batch/lot management
• Serialization
• Ability to place batches on hold

Transportation Management System Capabilities

• Automated notifications of delivery and pick up.
• Customized reporting, such as monthly shipping reports.

Standard Facility Features

Our facilities offer all clients at each of our facilities the following:

• 24/7 video surveillance
• Alarm systems with remote notification
• Access restricted to card keys. The restriction is granular and
• tailored to employee roles.
• Pest control
• Full liability insurance coverage

Free Quality Agreement Review

Moving from a service provider in the pharmaceuticals industry is tough. There are many nuances that a new service provider, whether it be warehousing or freight transportation, will need to understand and follow. You may begin discussions with a prospective warehousing or transportation service provider only to find out later that the service provider cannot do what is required.

This is why we provide a free, no-hassle review of your Quality Agreement. It will take you 30 seconds to submit and the potential benefits could be substantial, especially if your current logistics provider’s service level is declining.

ADLI Logistics will review your existing quality agreement and provide you with an answer to whether we can meet your requirements. Not only that, but we will also provide an estimate of how long it would take to onboard you and help you transition to one of our facilities.

Send us your quality agreement and a brief description of the raw and/or finished drugs we would be expected to handle and we will have our Quality Manager and Inventory Management team review it and get back to you.

If you are interested in your free quality agreement review, reach out to us via our contact us page and indicate that you have a quality agreement for us to review.